FDA Doesn’t Man Up: Fails to Recall Vagina Mesh

Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women. The product design and implantation technique contributed to serious complications, such as erosion and organ perforation.

In its response to a 2011 petition from Public Citizen, the FDA noted that it proposed earlier this year to require premarket approval of surgical mesh products used for transvaginal repair operations. The devices have been targeted in thousands of lawsuits alleging serious side effects, such as pain and incontinence, and for years have been cleared for sale along the less-arduous 510(k) approval pathway.

The FDA refused to go further by ordering recalls or banning the mesh products outright, but it also declined to shut the door on such enforcement, writing that it “may consider future action against individual products or this product type as appropriate.”

The response also noted that some manufacturers may not be able to satisfy the stringent safety and effectiveness standards of premarket approval. And it’s also possible that some companies may not even bother trying to meet the standards, as has sometimes been the case in recent years after the FDA issued 125 orders requiring intensive post-approval surveillance of device safety to more than 30 companies.

“As a result of these [surveillance] orders, many manufacturers have elected to cease marketing devices indicated for transvaginal mesh [pelvic organ prolapse] repair,” the FDA wrote.

Public Citizen’s petition had urged the FDA to adopt the premarket approval requirement for new mesh products. While the agency for technical reasons did not formally grant that request, regulators said their proposal earlier this year “initiated the process that could ultimately result in the action you seek.”

Michael Carome, director of Public Citizen’s Health Research Group and the petition’s author, said his group welcomes the move but remains troubled by the lengthy process surrounding stricter oversight of mesh devices.

The FDA first voiced concerns in 2008, and Carome noted that it could be several more years from now before the proposed order on premarket approval is finalized and new clinical trials are performed to gauge whether products should stay on the market.

“Obviously we were pleased that they were taking this step, but we know that this is a long overdue action, and we found it disturbing that it had taken so long,” Carome said.

In order to ban a medical device, the FDA is required under federal law to find that the product “presents substantial deception or an unreasonable and substantial risk of illness or injury.”

While regulators said in their response that they still believe sufficient benefits exist as compared with nonmesh surgical repairs, Carome accused the FDA of being too timid and said that enough evidence exists to halt sales.

“I think, as they do all too often, they’re bowing to the interests of [corporations] and not acting in the interests of patients and public health,” Carome said.

Comments are being accepted on the FDA’s premarket approval proposal through July 30.

Debate is also underway in Europe, where scientists have been tasked with re-evaluating the risk-benefit balance of mesh products and Scotland’s health secretary last month requested a temporary halt to sales of the devices.